MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CREA SLIDES; IN-VITRO DIAGNOSTIC

Catalog Number 6802584

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected, non-reproducible vitros na+, crea, and k+ results were obtained from 3 different patients when tested on a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause.However, based on reproducible results obtained from retesting, the customer concluded that the vitros results initially obtained from each sample were likely due to a pre-analytical sample related issue.The protocol used for pre analytical sample collection and processing at the alternate site is unknown, and therefore cannot be ruled out as a potential contributing factor.Although there were no indications of an instrument malfunction, a within-run precision marker test was not completed, and therefore, an instrument issue cannot be completely ruled out as a contributing factor to the event.Since no quality control data was provided, the performance of the affected assays is unknown and cannot be ruled out as contributing to the event.However, as the results for the patient samples were reproducible upon retesting the same samples, it is unlikely the vitros reagent lots in use contributed to the event.

Event Description

A customer observed lower than expected, non-reproducible vitros na+, crea, and k+ results obtained from 3 different patients when tested on a vitros 5600 integrated system.(b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action.The affected results were not reported to the physician, and there was no allegation of patient harm as a result of this event.This report is number 2 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6247992
• MDR Text Key: 65209909
• Report Number: 1319809-2017-00002
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 6802584
• Device Lot Number: 1507-3455-3429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1